`Bessler et al.
`
`US005855601A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,855,601
`Jan. 5, 1999
`
`[54] ARTIFICIAL HEART VALVE AND METHOD
`AND DEVICE FOR IMPLANTING THE
`SAME
`
`[75] Inventors: Marc Bessler, Teaneck, N.J.; Timothy
`A‘ M‘ chuter’ Malmo’ Sweden
`
`[73] Assignee: The Trustees of Columbia University
`III the City Of NEW YOI‘k, NGW YOI‘k,
`NY
`
`[21] App]' No‘: 668,376
`
`[22]
`
`Filed:
`
`Jun. 21, 1996
`
`[51] Int. Cl.6 ...................................................... .. A61F 2/24
`[52] US. Cl. ............................................... .. 623/2; 623/900
`[58] Field Of Search ................................... .. 623/2, 1, 900
`
`8/1992 Bowald .
`5,141,491
`5,152,771 10/1992 Sabbaghian et a1. .
`5,163,953 11/1992 Vince.
`5,297,564
`3/1994 Love .
`git/66122111“ '
`3/1995 Pavcnik et a1. ........................... .. 623/2
`
`5,397,351
`
`gilgeerrien et al' """""""""""" " 6230
`1/1996 COX _
`5:480:424
`2/1996 Piplani et al. ............................ .. 623/1
`5,489,295
`2/1996 Love et al. .
`5,489,298
`5,562,729 10/1996 Purdy et al. .............................. .. 623/2
`5,571,175 11/1996 Vanney et al. ............................ .. 623/2
`
`FOREIGN PATENT DOCUMENTS
`
`164494“ 4/1991 Russian Fedem?ml
`W0
`[515??? """"""""""""""""""" " 623/2
`
`[56]
`
`_
`References Clted
`
`WO 91/17720 11/1991 WIPO .
`9407437 4/1994 WIPO ...................................... .. 623/2
`
`U.S. PATENT DOCUMENTS
`
`4/1971 Hamaker ................................... .. 623/2
`3,574,865
`6/1972 Moulopoulos'
`376717979
`4/1975 King et a1. .
`3,874,388
`4,056,854 11/1977 Boretos et al. .
`4,592,340
`6/1986 Boyles.
`4,631,052 12/1986 Kensey.
`4,692,139
`9/1987 Stiles -
`4,705,507 11/1987 Boyles -
`477947928
`1/1989 Kletschka '
`‘H1 et a1’ """""""""""" " 623/2
`4:886:061 12/1989 Fischen et a1‘ '
`479607424 10/1990 (hooters _
`479667604 10/1990 Reiss _
`4,979,939 12/1990 Shiber.
`4,994,077
`2/1991 Dobben .
`5,007,896
`4/1991 Shiber -
`570197090
`5/1991 Pinchuk -
`5,032,128
`7/1991 Alonso '
`5’047’041
`9/1991 samufa’ls '
`5,069,679 12/1991 Tahen.
`5,080,660
`1/1992 Buelna .
`5,133,725
`7/1992 Quadri .
`
`Primary Examiner—Michael J. Milano
`Assistant Examiner_Tram A_ Nguyen
`Attorney, Agent, or Firm—CoWan, LieboWitZ & Latman,
`RC, William H‘ Dippert
`’
`[57]
`
`ABSTRACT
`
`An arti?cial heart valve comprises a relatively rigid stent
`member having a ?rst cylindrical shape and a ?exible valve
`disposed in the stent member, the stent member being
`self-expandable to a second cylindrical shape and co'llaps
`ible to its ?rst cylindrical shape. The valve comprises a
`circular portion comprising a plurality of lea?ets extending
`from the periphery of the circular portion toWards the center
`thereof, the lea?ets being con?gured to alloW for ?oW of
`blood through the valve in one direction only. The diameter
`of the circular portion is substantially the same as the inside
`diameter of the stent member When the stent member is in
`its second cylindrical shape, the valve member being
`attached to the stent member.
`
`20 Claims, 8 Drawing Sheets
`
`A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 1 of 15
`
`
`
`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 1 of8
`
`5,855,601
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 2 of 15
`
`
`
`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 2 of8
`
`5,855,601
`
`Wu. F
`4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 3 of 15
`
`
`
`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 3 of8
`
`5,855,601
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 4 of 15
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`
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`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 4 of s
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`5,855,601
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`I IIII~~
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`1 0
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`C 5..
`09 v
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`z. I‘
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`m QR g
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`A’.
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`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 5 of 15
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`
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`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 5 of8
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`5,855,601
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 6 of 15
`
`
`
`Jan. 5, 1999
`
`Sheet 6 of 8
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`5,855,601
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 7 of 15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 7 of 15
`
`
`
`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 7 0f 8
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`5,855,601
`
`F /G /4
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`F /6 l5
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`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 8 of 15
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`
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`U.S. Patent
`
`Jan. 5, 1999
`
`Sheet 8 of8
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`5,855,601
`
`FIG: /6
`
`A/
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 9 of 15
`
`
`
`1
`ARTIFICIAL HEART VALVE AND METHOD
`AND DEVICE FOR IMPLANTING THE
`SAME
`
`FIELD OF THE INVENTION
`
`The present invention relates to novel arti?cial heart
`valves. More particularly, the present invention relates to
`novel heart valves that are especially adapted for placement
`using minimally invasive surgical techniques and to the
`method and device useful for such placement.
`
`BACKGROUND OF THE INVENTION
`
`Over the past several years a number of less invasive or
`minimally invasive surgical techniques have been devel
`oped. Examples of such techniques are various endoscopic
`or laparoscopic procedures, angioplasty procedures, atherec
`tomy procedures, and the like. While the instruments and
`devices used in these minimally invasive procedures are
`complex and hence relatively expensive, the procedures are
`gaining more and more acceptance. It is believed the reasons
`for this acceptance are the reduced risk to the patient, as the
`patient often doesn’t have to undergo general anesthesia or
`the time under general anesthesia is greatly reduced.
`Perhaps, more importantly, the recovery time required after
`a minimally invasive procedure is much less, thus greatly
`reducing hospital costs.
`One of the more invasive procedures being performed
`today is open heart surgery. Such procedures require the use
`of general anesthesia, sternotomy, use of extracoporeal
`by-pass, recovery in an intensive care unit, and a stay of at
`least a feW days in the hospital. Although such procedures
`carry a loW mortality rate, they are quite expensive.
`Currently in the United States approximately 100,000
`defective heart valves are replaced annually, at an approxi
`mate cost of $30—50,000 per procedure, and thus it Would be
`desirable if heart valves could be replaced using minimally
`invasive techniques. It Would be especially advantageous if
`a defective heart valve could be removed via an endovas
`cular procedure, that is, a procedure Where the invasion into
`the body is through a blood vessel such as the femoral artery.
`The procedure is then carried out percutaneously and trans
`luminally using the vascular system to convey appropriate
`devices to the position in the body Wherein it is desired to
`carry out the desired procedure. An example of such a
`procedure Would be angioplasty, Wherein a catheter carrying
`a small balloon at its distal end is manipulated through the
`body’s vessels to a point Where there is a blockage in a
`vessel. The balloon is expanded to create an opening in the
`blockage, and then the balloon is de?ated and the catheter
`and balloon are removed from the vessel.
`Endovascular procedures have substantial bene?ts both
`from the standpoint of health and safety as Well as cost. Such
`procedures require minimal invasion of the human body, and
`there is consequently considerable reduction and in some
`instances even elimination, of the use of a general anesthesia
`and much shorter hospital stays.
`In the last feW years a number of atherectomy devices
`have been developed. These are endovascular devices used
`to remove plaque and other abnormal deposits from vessels.
`Representative examples of such devices are those disclosed
`in US. Pat. Nos. 4,445,509, 4,646,736, and 4,990,134.
`Anumber of minimally invasive techniques for replacing
`heart valves have been developed. Such techniques have
`been reported in an article by H. R. Andersen et al., entitled
`“Transluminal Implantation of Arti?cial Heart Valves”,
`
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`European HeartJournal (1992), Vol. 13, pp. 704—708; in an
`article by L. L. Knudsen et al., entitled “Catheter-Implanted
`Prosthetic Heart Valves”, The International Journal ofArti
`?cial Organs, Vol. 16, No. 5 (1993), pp. 253—262; and in an
`article by D. Pavcnik et al., entitled “Development and
`Initial Experimental Evaluation of a Prosthetic Aortic Valve
`for Trans-Catheter Placement”, Radiology (1992), Vol. 183,
`pp. 151—154. While the devices and techniques reported are
`clearly experimental, it appears that each of them suffers
`from one or more of the folloWing problems: (1) secure
`placement of the heart valve; (2) durability of the heart
`valve; (3) ease of placement; (4) thrombogenicity, (5) leak
`age or regurgitation of blood, (6) excessive pressure gradient
`across the valve, and (7) siZe of the device and delivery
`system, as Well as other similar problems. In addition, none
`of the above described devices or methods deals With the
`presence of a diseased or defective native valve.
`An endovascular valve replacement procedure is
`described in Stevens, US. Pat. No. 5,370,685. While it
`cannot be discerned Whether the procedure disclosed Will
`Work, it is evident that the replacement valve is structurally
`limited and Will have the disadvantages associated With the
`problems discussed above.
`
`OBJECTS OF THE INVENTION
`It is an object of the present invention to provide endo
`vascular procedures and devices for the percutaneous and
`transluminal replacement of diseased or defective heart
`valves.
`It is also an object of the present invention to provide a
`heart valve that can be relatively easily placed and secured
`in position.
`It is a further object of the present invention to provide a
`valve that is relatively non-thrombogenic and eliminates
`undesirable leakage.
`It is a still further object of the present invention to
`provide a method and device for the simple placement and
`securement of the neW and improved heart valve in the
`desired position in a patient.
`It is likeWise an object of the present invention to provide
`a method and device for implanting an arti?cial heart valve
`using minimally invasive techniques especially endovascu
`lar techniques.
`It is an even further object of the present invention to
`provide a method and device for the percutaneous and
`transluminal removal of a defective heart valve.
`It is additionally a further object of the present invention
`to provide for the minimally invasive or endovascular place
`ment of heart valves While preventing emboliZation.
`These and other objects of the invention Will become
`more apparent in the discussion beloW.
`
`SUMMARY OF THE INVENTION
`The invention herein encompasses methods and devices
`for the endovascular removal and replacement of diseased or
`defective heart valves. The invention includes a neW heart
`valve Which may be implanted percutaneously and
`transluminally, Which heart valve comprises a stent member
`and a valve means. The stent member is self-expanding and
`has Within it valve means that permit How in only one
`direction. Preferably the stent member has barbs Which
`anchor the expanded stent member at a desired site. A
`cutting mechanism is used to remove the diseased or defec
`tive heart valve, and then the replacement valve is inserted
`percutaneously to the site, Where it is released in a controlled
`fashion from the distal end of a catheter.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 10 of 15
`
`
`
`3
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a front, partially cross-sectional vieW of an
`arti?cial heart valve of the present invention;
`FIG. 2 is a top vieW of the arti?cial heart valve depicted
`in FIG. 1;
`FIG. 3 is a bottom vieW of the arti?cial heart valve
`depicted in FIG. 1;
`FIG. 4 is a perspective, partially cross-sectional vieW of
`an arti?cial heart valve of the invention in an expanded
`con?guration;
`FIG. 5 is a perspective vieW of an arti?cial heart valve of
`the invention in a collapsed or constrained con?guration;
`FIG. 6 is an expanded front vieW of a segment of one type
`of stent member that may be used in the arti?cial heart
`valves of the invention;
`FIG. 7 is a front, partially cross-sectional vieW of another
`embodiment of an arti?cial heart valve of the invention;
`FIG. 8 is a partially cross-sectional vieW of a device
`according to the invention for removing a defective or
`diseased heart valve;
`FIG. 9 is an enlarged, cross-sectional vieW of the distal
`end of the device shoWn in FIG. 8;
`FIG. 10 is a vieW taken along line 10—10 of FIG. 9;
`FIG. 11 is a vieW taken along line 11—11 of FIG. 9;
`FIG. 12 is a cross-sectional vieW of a device of the
`invention for the percutaneous and transluminal implanta
`tion of a heart valve;
`FIG. 13 is an enlarged, cross-sectional vieW taken along
`line 13—13 of FIG. 12;
`FIG. 14 is an enlarged, cross-sectional vieW of the distal
`end of the device depicted in FIG. 12 shoWing the heart
`valve of the invention in a partially ejected state;
`FIG. 15 is an enlarged, cross-sectional vieW of the distal
`end of the device depicted in FIG. 12 shoWing the heart
`valve fully ejected from the device; and
`FIG. 16 is a partially cross-sectional vieW of an arti?cial
`heart valve according to the invention useful for venous
`insuf?ciency.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`The present invention includes methods and devices for
`implanting a heart valve percutaneously and transluminally.
`The arti?cial heart valves of the invention, Which are
`capable of exhibiting a variable diameter betWeen a com
`pressed or collapsed position and an expanded position,
`comprise (1) a relatively rigid stent member and (2) a
`?exible valve means. The stent member is self-expanding
`and has a ?rst cylindrical shape in its compressed or col
`lapsed con?guration and a second, larger cylindrical shape
`in its expanded con?guration. The ?exible valve means
`comprises a generally arcuate center portion and, preferably,
`a peripheral upstanding cuff portion. The ?exible valve
`means is disposed Within the cylindrical stent member With
`the arcuate portion transverse of and at some acute angle
`relative to the stent Walls. The diameter of the arcuate
`portion is substantially the same as the inside diameter of the
`stent member in its initial expanded con?guration. The
`peripheral upstanding cuff portion is disposed substantially
`parallel to the Walls of the stent member.
`The arcuate portion of the valve means contains at least
`one slit to form lea?ets Which open in response to blood ?oW
`in one direction and close in response to blood ?oW in the
`
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`opposite direction. Preferably the arcuate portion of the
`valve means contains a plurality of lea?ets and most pref
`erably three lea?ets.
`The cuff portion of the valve means is attached to the stent
`member and may extend partly or Wholly around the outer
`perimeter of the stent member. In some of the preferred
`embodiments of the arti?cial heart valve of the invention,
`the cuff portion of the valve means extends on only one side
`of the circular portion of the stent member. The ?exible
`valve means preferably comprises porcine pericardium con
`?gured With three lea?ets.
`Preferably the stent member carries a plurality of barbs
`extending outWardly from the outside surface of the stent
`member for ?xing the heart valve in a desired position. More
`preferably the barbs are disposed in tWo spaced-apart, cir
`cular con?gurations With the barbs in one circle extending in
`an upstream direction and the barbs in the other circle
`extending in a doWnstream direction. It is especially pref
`erable that the barbs on the in?oW side of the valve point in
`the direction of ?oW and the barbs on the out?oW side point
`in the direction opposite to ?oW. It is preferred that the stent
`be formed of titanium alloy Wire or other ?exible, relatively
`rigid, physiologically acceptable material arranged in a
`closed Zig-Zag con?guration. Such a con?gured stent mem
`ber Will readily collapse and expand as pressure is applied
`and released, respectively.
`The invention includes methods and devices for the
`percutaneous and transluminal removal of the diseased or
`defective heart valve and the percutaneous and transluminal
`implantation of the neW heart valve described above. The
`defective heart valve is removed by a suitable modality, such
`as, for example, laser, ultrasound, mechanical, or other
`suitable forms of delivery of energy, or phacoemulsion,
`including, but not limited to, laser lithotripsy, mechanical
`lithotripsy, electrohydraulic lithotripsy, and laser or
`mechanical ablation. For example, the valve can be ground
`or cut into ?ne particles or pieces and the particles are
`gathered and removed. The device for grinding or cutting the
`defective heart valve and removing the debris can include a
`rotating cutting tool mounted on the end of a ?exible drive
`shaft. The drive shaft is surrounded over most of its length
`by a guiding catheter. The cutting tool, Which is inserted into
`a vessel of the patient and guided to the location of the
`defective heart valve, may comprise cutting blades disposed
`at its distal end. The blades are con?gured such that the
`debris that is created by the cutting action is throWn or
`ejected proximal of the distal end. Disposed close to the
`cutting blades and proximal thereof is a collecting member
`Which preferably has a concave shape and is expandable to
`occlude the aorta as Well as to catch debris. If desired the
`collecting member may be perforated so that suction may be
`used to aid in the removal of the ground debris.
`The system for implanting the above described arti?cial
`heart valve percutaneously and transluminally includes a
`?exible catheter Which may be inserted into a vessel of the
`patient and moved Within that vessel. The distal end of the
`catheter, Which is holloW and carries the arti?cial heart valve
`of the present invention in its collapsed con?guration, is
`guided to a site Where it is desired to implant the arti?cial
`heart valve. The catheter has a pusher member disposed
`Within the catheter lumen and extending from the proximal
`end of the catheter to the holloW section at the distal end of
`the catheter. Once the distal end of the catheter is positioned
`as desired, the pusher mechanism is activated and the distal
`portion of the arti?cial heart valve is pushed out of the
`catheter and the stent member partially expands. In this
`position the stent member is restrained so that it doesn’t pop
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 11 of 15
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`5,855,601
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`5
`out and is held for controlled release, With the potential that
`the arti?cial heart valve can be recovered if there is a
`problem With the positioning or the like. The catheter is them
`retracted slightly and the arti?cial heart valve is completely
`pushed out of the catheter and released from the catheter to
`alloW the stent member to fully expand. If the stent member
`includes tWo circles of barbs on its outer surface as previ
`ously described, the ?rst push and retraction Will set one
`circle of barbs in adjacent tissue and the second push and
`release of the arti?cial heart valve Will set the other circle of
`barbs in adjacent tissue and securely ?x the arti?cial heart
`valve in place When the valve is released from the catheter.
`Alternatively, or in combination With the above, the heart
`valve could be positioned over a guideWire.
`The invention can perhaps be better appreciated by ref
`erence to the draWings. An arti?cial heart valve according to
`the present invention is set forth in FIGS. 1 to 3. The
`arti?cial heart valve 20 is comprised of a stent member 21
`and a ?exible valve means 22. In this embodiment the stent
`member 21 is comprised of stainless steel Wire in a sine
`Wave-like con?guration as shoWn in FIG. 1. The center
`portion 23 of valve member 22 is generally arcuate in shape
`and comprises three lea?ets 24 as shoWn, although it is
`understood that there could be from 2 to 4 lea?ets. A cuff
`portion 25 extends from the periphery of the circular portion
`27 along the outside of the stent member 21 and is attached
`to the stent member 21 by a plurality of sutures 26.
`FIG. 4 is a perspective vieW of another embodiment of an
`arti?cial heart valve 30 of the invention. The heart valve 30
`has a generally circular shape With the Walls 31 of the
`cylinder being formed by the stent member 32. The stent
`member 32 is a Wire formed in a closed Zig-Zag con?gura
`tion. The member has an endless series of straight sections
`33 joined by bends 34. The valve member 35 is ?exible and
`includes a plurality of lea?ets 36.
`The lea?et portion of the valve member 35 extends across
`or transverse of the cylindrical stent. The lea?ets 36 are the
`actual valve and alloW for one-Way ?oW of blood. Extending
`from the periphery of the lea?et portion is a cuff portion 37.
`The cuff portion 37 extends adjacent the stent Walls 31 in the
`direction of the arroW A. The cuff portion is attached to the
`stent by sutures 38.
`The con?guration of the stent member 32 and the ?exible,
`resilient material of construction alloWs the valve to collapse
`into a relatively small cylinder 40 as seen in FIG. 5. The
`arti?cial heart valve Will not stay in its collapsed con?gu
`ration Without being restrained. Once the restraint is
`removed, the self-expanding stent member 32 Will cause the
`arti?cial heart valve to take its expanded con?guration, as
`seen in FIG. 4.
`An enlarged vieW of a preferred embodiment of a stent
`member for use in the arti?cial heart valve of the invention
`is depicted in FIG. 6. The stent member 50 includes a length
`of Wire 51 formed in a closed Zig-Zag con?guration. The
`Wire can be a single piece, stamped or extruded, or it could
`be formed by Welding the free ends together as at 52. The
`straight sections 53 of the stent are joined by bends 54. The
`stent is readily compressible to a small cylindrical shape and
`resiliently self-expandable to the shape shoWn in FIG. 6.
`Another embodiment of the arti?cial heart valve of the
`present invention is depicted in FIG. 7. In this embodiment
`the heart valve 60 has a modi?ed sine Wave con?guration.
`As seen in the draWing every other Wave 61 has approxi
`mately 0.50—0.75 the amplitude of adjacent Waves 62. The
`?exible valve member 63 is disposed at the croWn or top of
`the smaller Waves. The larger Waves carry a plurality of
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`barbs 64 for holding the valve in place once it has been
`appropriately positioned.
`The stent members of the arti?cial heart valves of the
`present invention may be made from Elgiloy alloy, titanium,
`titanium alloy, nitinol, stainless steel, or other resilient,
`?exible non-toxic, non-thrombogenic, physiologically
`acceptable and biocompatible materials. The con?guration
`may be the Zig-Zag con?guration shoWn or a sine Wave
`con?guration, mesh con?guration or a similar con?guration
`Which Will alloW the stent to be readily collapsible and
`self-expandable. When a Zig-Zag or sine Wave con?gured
`stent member is used, the diameter of the Wire from Which
`the stent is made should be from about 0.010 to 0.035 inches,
`preferably from about 0.012 to 0.025 inches. The diameter
`of the stent member Will be from about 1.5 to 3.5 cm,
`preferably from about 1.75 to 3.00 cm, and the length of the
`stent member Will be from about 1.0 to 10 cm, preferably
`from about 1.1 to 5 cm.
`The valve member is ?exible, compressible, host
`compatible, and non-thrombogenic. The valve can be, for
`example, a glutaraldehyde ?xed porcine aortic valve Which
`has three cusps that open distally to permit unidirectional
`blood ?oW. The valve can also be fresh, cryopreserved or
`glutaraldehyde ?xed allografts or xenografts. The optimal
`material Will be synthetic such that it is manufactured from
`non-biological materials, non-thrombogenic, ?exible such
`that it can be transported through the vasculature, biocom
`patible and very durable such that it can Withstand a per
`manent ?xation at the valve site. Biocompatible materials
`such as polytetra?uoroethylene, polyester and the like may
`be used.
`In FIGS. 8 through 11 there is shoWn a device for the
`percutaneous and transluminal removal of a diseased or
`defective heart valve. The device 70 includes a cutting tool
`71 disposed at the distal end of the device 70. As shoWn in
`FIG. 10 cutting tool 71 has a plurality of abrasive surfaces
`72 on its outer surface for cutting or grinding aWay the
`defective heart valve. Abrasive surfaces 72 comprise dia
`mond chips, small metal blades, or other similar abrading
`means that Would be effective to safely remove the defective
`heart valve. The cutting tool 71 is rotated by a ?exible
`transluminal drive shaft 73, Which is preferably contained
`along substantially its entire length in a ?exible catheter 74
`made of physiologically acceptable plastic material. At the
`proximal end of the catheter 74 remote from the cutting tool
`71 there is a catheter connector 75 to connect the catheter 74
`to a drive shaft bearing block 76. The bearing block includes
`a central cavity 77 and a port 78. The proximal end of the
`drive shaft 73 is connected to and through a prime mover or
`motor 79 for rotation of drive shaft 73 and cutting tool 71.
`As is more clearly shoWn in FIG. 9, disposed just proxi
`mal of the cutting tool 71 is a collecting member 80 for
`collecting debris generated by the cutting or grinding aWay
`of the defective heart valve. The collecting member is
`circular, preferably With a concave shape for directing debris
`toWard the annular space 81 betWeen drive shaft 73 and
`catheter 74. Suction may be applied to the port 78 in bearing
`block 76 to assist in removal of debris from the operative
`site. Collecting member 80 preferably expands due to an
`in?atable component to cause the outWard radial portion of
`collecting member 80 to abut the inner surface of the
`appropriate vessel. Thus, all or part of collecting member 80
`could be in?atable either in a single in?atable member or a
`series of in?atable members. Catheter 74 Would contain one
`or more in?ation lumens, not shoWn, in ?uid communication
`With the one or more parts of collecting member 80 to be
`in?ated.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1033, p. 12 of 15
`
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`5,855,601
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`7
`It is preferred that the cutting tool 71 have an initial,
`relatively small diameter con?guration and then a larger
`con?guration as drive shaft 73 and cutting tool 71 are
`rotated. Alternatively, cutting tool 71 could be mechanically
`connected to a mechanical rod extending to the proximal end
`of catheter 74 to cause cutting tool 71 to expand prior to
`contact With the defective heart valve.
`Suction may be applied to the port 78 in the bearing block
`76 to assist in the removal of debris from the operative site.
`Distal protective balloon 82 Which is in?ated through a
`lumen in catheter 86 Within drive shaft 73, is in?ated to a
`diameter slightly larger than the extended diameter of cut
`ting tool 71.
`It is preferred that both the cutting tool 71 and the
`collecting member 80 be expandable. In the embodiment
`shoWn the cutting tool 71 comprises a plurality of leaves 83
`and the collecting member basin 80 also comprises a plu
`rality of leaves 84. In both instances the leaves may be
`mechanically contracted so as to overlap adjacent leaves and
`reduce the diameter of the respective unit. This Will alloW
`both units to be collapsed While being inserted in the vessel
`and guided to the operative site. The cutting 71 tool is then
`rotated at a relatively high speed of 3000 to 4000 rpm to
`grind aWay the defective valve. The resultant debris is
`collected in the collecting member 80 and removed from the
`site With the aid of suction.
`The device set forth in FIGS. 12 and 13 represents a novel
`device for implanting the arti?cial heart valves of the present
`invention. The device 90 comprises a ?exible catheter 91 for
`percutaneous and transluminal delivery of the heart valve to
`the desired site. A heart valve 92 of the invention is carried,
`in its collapsed state, at the distal end of the catheter 91
`Where the catheter Walls maintain the valve 92 in its col
`lapsed state. Disposed Within the catheter 91 is a holloW
`?exible pusher member 93, Which is movable longitudinally
`With respect to the catheter 91. A guideWire 94 having a
`blunt end 95 is disposed through a lumen 97 of the pusher
`member 93 and is used to guide the distal end of the catheter
`91 to the desired site. Means 96 is also disposed through
`lumen 97 of the pusher member 93 for holding the valve 92
`in place and alloWing release of the valve 92 When desired,
`as Will be more fully described in conjunction With FIGS. 14
`and 15.
`In FIG. 14 there is shoWn an implanting device 100 of the
`present invention With a heart valve 101 partially ejected,
`and FIG. 15 shoWs the device 100 With the heart valve 101
`fully ejected. In FIG. 14 the catheter 102 has been brought
`to the appropriate site and the guide Wire removed proxi
`mally. The pusher member 103 has been moved forWard
`longitudinally of the catheter 102 to eject approximately
`one-half of the heart valve 101 from the distal end of the
`catheter 102. As seen in the draWing the distal end of the
`valve 101 is expanded and a slight pull of the entire unit Will
`set the ?rst circle of barbs 104 in the vessel Wall. The heart
`valve 101 is held in place Within the delivery catheter by a
`pair of threads or sutures 105. The sutures are looped
`through an opening 106 in the pusher member 103 and then
`passed about a portion of the heart valve 101 as shoWn. The
`other end of the suture 105 contains a loop 107. A tension
`thread 108 is passed through the suture loops and doWn
`through the center of the pusher member 103 to the proximal
`end of the catheter 102. As seen in FIG. 15 the heart valve
`101 has been completely ejected from the catheter 102. The
`tension thread 108 has been removed and the pusher mem
`ber 103 longitudinally retracted. The looped sutures have
`been disengaged from the heart valve 101 and the second
`circle of barbs 109 set in the vessel Wall and the valve
`implanted.
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`8
`Before the invention herein is used, the patient is studied
`to determine the architecture of the patient’s heart. Useful
`techniques include ?uoroscopy, transesophageal
`echocardiography, MRI, and angiography. The results of this
`study Will enable the physician to determine the appropriate
`siZed cutting tool and heart valve to employ.
`To use Applicant’s invention, a guideWire is inserted
`percutaneously and transluminally using standard vascular
`or angiography techniques. The distal end of the guideWire
`is manipulated to extend through and across the defective
`heart valve. Then a catheter corresponding to catheter 74 is
`advanced distally through the femoral artery to a point
`proximal to the defective heart valve, betWeen the origin of
`the coronary artery and the origin of the right subclavian
`artery. The position of the distal end of catheter 74 can be
`monitored by observation of radiopaque markers. Collector
`member 80 is preferably in?ated and occludes the aorta at a
`point betWeen the origin of the coronary artery and the right
`subclavian artery. Next, balloon 87 and cutting tool 71 are
`advanced through catheter 74 so that the cutting tool 71 and
`unin?ated balloon 87 are distal to the defective heart valve.
`Optionally an additional step, such as balloon dilatation or
`atherectomy, may be required to provide a passageWay
`through the heart valve.
`A catheter is placed into the coronary sinus via a trans
`jugular puncture. This catheter is used for infusion of blood
`or cardioplegia solution during the portion of the procedure
`When the aorta is occluded. The absence of valves in the
`cardiac venous system alloWs retrograde ?oW so that there
`Will be an ef?uence of ?uid from the coronary arteries. This
`?oW of ?uid is desired to prevent emboliZation of material
`into the coronary arteries during the procedure.
`Once the cutting tool 71 is in place, the balloon 82 is
`in?ated and ?exible shaft 73 is rotated. Once cutting tool 71
`has reached the appropriate rotation speed, cutting tool 71 is
`pulled proximally to remove the defective heart valve.
`Balloon 87 and cutting tool 71 are spaced apart so that
`in?ated balloon 87 Will be stopped by the perimeter, unre
`moved portion of the defective heart valve, Which Will signal
`the physician that the valve has been removed, as Well as
`protect the heart and aorta from damage from the valve
`removal device. Also, the spacing is such that the cutting
`tool Will not co